Axsome Therapeutics, Inc. 8K

Axsome Therapeutics' NDA for AXS-12 to treat cataplexy in narcolepsy has been accepted by the FDA with a PDUFA target action date of May 1, 2027.

Axsome Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy and established a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027, while indicating it does not currently plan to hold an advisory committee meeting to discuss the application.

Filing Facts

CIK

1579428

Ticker

AXSM

Form

8K

Source Type

fda

Accession

0001193125-26-304039

Alert Tier

6